Methods

Data from two independent multicenter, randomised, double–blind, placebo–controlled, 6–month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5–ASA formulations to MG 1.5 g or placebo upon randomisation.

The primary endpoint was the percentage of patients who remained relapse–free at Month 6 or end of treatment.

Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare.

Results

Of the 487 patients who received 5–ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group.

The percentage of patients who remained relapse–free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001).

Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint).